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EC number: 229-929-1 | CAS number: 6843-66-9
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 12 Jun to 12 Jul 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1997)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Dimethoxydiphenylsilane
- EC Number:
- 229-929-1
- EC Name:
- Dimethoxydiphenylsilane
- Cas Number:
- 6843-66-9
- Molecular formula:
- C14H16O2Si
- IUPAC Name:
- dimethoxydiphenylsilane
- Details on test material:
- - Name of test material (as cited in study report): Dimethoxy diphenylsilane
- Physical state: clear colourless liquid
- Lot/batch No.: C42008
- Storage condition of test material: room temperature over silica gel, in darkness under nitrogen
- Date of delivery: 2002-04-02
Constituent 1
Method
- Target gene:
- HIS operon (S. typhimurium), TRP operon (E. coli)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix from phenobarbitone/ß-naphthoflavone induced male Sprague-Dawley rats
- Test concentrations with justification for top dose:
- - Range-finding study (cytotoxicity): 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500, and 5000 µg/plate
- Range-finding study: 50, 150, 500, 1500, and 5000 µg/plate
- Main study: 50, 150, 500, 1500, and 5000 µg/plate
- Confirmatory study: 500, 1000, 1500, 3000, and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO (prior to experiment dried over molecular sieves (sodium alumino-silicate) ie 2 mm pellets with a nominal pore diameter of 4 x 10 E-4 microns)
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- without metabolic activation Migrated to IUCLID6: 2 mg/plate for WP2uvrA-, 3 µg/plate for TA100, and 5 µg/plate for TA1535
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without metabolic activation Migrated to IUCLID6: 50 µg/plate for TA1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without metabolic activation Migrated to IUCLID6: 0.2 µg/plate for TA98
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene 1µg/plate for TA100, 2 µg/plate for TA 1535 and TA 1537, 10 µg/plate for WP2 uvrA-
- Remarks:
- with metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with metabolic activation Migrated to IUCLID6: 5 µg/plate for TA98
- Details on test system and experimental conditions:
- METHOD OF APPLICATION
- Range-finding study: in agar (plate incorporation)
- Main study: in agar (plate incorporation)
- Confirmatory study: in agar (plate incorporation) and preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: 3 independent experiments were carried out
- Range-finding study: 3 plates
- Main study: 3 plates
- Confirmatory study: 5 plates (only TA1535 without metabolic activation)
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency (preliminary study, only with TA100 and WP2uvrA-) - Evaluation criteria:
- The test material may be considered positive in this test system if it has induced a reproducible, dose-related and statistically significant increase in the revertant count in at least one strain of bacteria.
- Statistics:
- Dunnet's method of linear regression
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvrA
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- bacteria, other: TA 1537, TA 98, TA 100, WP2 uvrA-
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- none
Any other information on results incl. tables
Tab. 1: Test results from the range-finding study.
Test material |
TA 100 |
TA 1535 |
WP2 uvrA |
TA 98 |
TA 1537 |
||||||
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
||
Solvent control |
104 ± 5.2 |
110 ± 10.1 |
22 ± 6.1 |
23 ± 2.1 |
23 ± 3.8 |
24 ± 11.1 |
33 ± 8.3 |
23 ± 1.7 |
25 ± 6.1 |
18 ± 3.1 |
|
Test item |
50 µg/plate |
106 ± 13.0 |
93 ± 4.4 |
22 ± 4.6 |
33 ± 6.6 |
24 ± 0.6 |
20 ± 1.7 |
36 ± 4.7 |
19 ± 3.5 |
31 ± 1.7 |
18 ± 5.0 |
150 µg/plate |
102 ± 7.2 |
86 ± 15.9 |
18 ± 3.8 |
40 ± 7.9 |
24 ± 3.2 |
26 ± 5.7 |
35± 1.5 |
22 ± 2.6 |
25 ± 8.3 |
20 ± 2.5 |
|
500 µg/plate |
97 ± 8.0 |
112 ± 2.9 |
18 ± 2.9 |
51 ± 6.7** |
24 ± 3.8 |
17 ± 0.6 |
37 ± 3.6 |
20 ± 3.5 |
20 ± 3.5 |
17 ± 0.6 |
|
1500 µg/plate |
80 ± 15.5 |
104 ± 14.8 |
15 ± 3.5 |
60 ± 11.5*** |
16 ± 4.0 |
14 ± 4.9 |
37 ± 3.0 |
17 ± 1.2 |
23 ± 1.7 |
19 ± 2.1 |
|
5000 µg/plate |
82 ± 6.4 |
97 ± 13.6 |
13± 2.9 |
51 ± 18.2** |
15 ± 4.7 |
17 ± 3.5 |
32 ± 9.5 |
21 ± 2.1 |
19 ± 4.6 |
14 ± 3.2 |
|
Positive control |
2388 ± 68.8 |
395 ± 300.8 |
215 ± 9.2 |
603 ± 75.0 |
1213 ± 26.3 |
765 ± 30.4 |
228 ± 0.6 |
158 ± 8.4 |
292 ± 47.4 |
2091 ± 232.8 |
|
** p ≤ 0.01 *** p ≤ 0.005
Tab. 2: Test results from the main study
Test material |
TA 100 |
TA 1535 |
WP2 uvrA |
TA 98 |
TA 1537 |
||||||
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
||
Solvent control |
89 ± 5.0 |
86 ± 13.3 |
15 ± 3.5 |
28 ± 3.8 |
20 ± 3.6 |
18 ± 3.6 |
38 ± 3.6 |
21 ± 7.5 |
17 ± 4.0 |
9 ± 4.5 |
|
Test item |
50 µg/plate |
96 ± 11.0 |
93 ± 16.4 |
15 ± 2.5 |
30 ± 6.7 |
24 ± 1.2 |
23 ± 3.6 |
34 ± 5.3 |
15 ± 2.6 |
18 ± 4.5 |
6 ± 1.0 |
150 µg/plate |
87 ± 5.0 |
96 ± 16.5 |
14 ± 1.2 |
38 ± 9.6 |
21 ± 5.5 |
26 ± 6.9 |
33 ± 6.0 |
17 ± 5.2 |
19 ± 3.6 |
7 ± 1.5 |
|
500 µg/plate |
103 ± 11.4 |
111 ± 10.1 |
19 ± 1.2 |
51 ± 3.5*** |
26 ± 6.4 |
21 ± 9.3 |
42 ± 6.2 |
20 ± 1.5 |
18 ± 2.5 |
9 ± 2.5 |
|
1500 µg/plate |
76 ± 15.0 |
113 ± 6.0 |
16 ± 2.0 |
43 ± 3.8* |
20 ± 2.3 |
16 ± 3.6 |
43 ± 9.3 |
15 ± 7.0 |
19 ± 4.0 |
13± 4.0 |
|
5000 µg/plate |
59 ± 6.2 |
92 ± 13.6 |
10 ± 2.6 |
41 ± 3.6* |
17 ± 1.5 |
8 ± 3.2 |
37 ± 10.4 |
12 ± 3.0 |
19 ± 1.7 |
3 ± 1.0 |
|
Positive control |
1963 ± 315.0 |
378 ± 99.3 |
174 ± 26.9 |
282 ± 7.2 |
610 ± 116.8 |
918 ± 18.9 |
129 ± 21.0 |
114 ± 9.5 |
328 ± 17.4 |
2200 ± 122.0 |
|
* p ≤ 0.05 *** p ≤ 0.005
Tab. 3: Test results from the confirmatory study
Test material |
TA 1535 |
||
Preincubation Method |
Plate incorporation Method |
||
Solvent control |
20 ± 3.0 |
21 ± 4.5 |
|
Test item |
500 µg/plate |
43 ± 9.8*** |
41 ± 9.4*** |
1000 µg/plate |
48 ± 9.6*** |
44 ± 8.2*** |
|
1500 µg/plate |
42 ± 7.7 *** |
41 ± 5.8*** |
|
3000 µg/plate |
54.6 ± 7.6*** |
52 ± 10.5*** |
|
5000 µg/plate |
50 ± 6.3*** |
49 ± 8.3*** |
|
Positive control |
667 ± 71.0 |
667 ± 71.0 |
|
*** p ≤ 0.005
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: positive without metabolic activation in TA 1535
Dimethoxydiphenysilane has been tested according to OECD 471 (1997) and in compliance with GLP in Salmonella typhimurium strains TA 98, TA 100, TA 1535 and TA 1537, as well as in Escheria coli WP2uvrA-. No increase in revertants was detected at any concentration up to the limit concentration, with metabolic activation in the plate incorporation test. In addition, no mutagenicity was observed in TA 98, TA 100, TA 1537, and WP2uvrA- in the absence of an metabolic activation system. In contrast, TA 1535 showed statistically significant increases of revertants in both the range-finding study and in the main study. A confirmatory experiment testing this strain in the plate incorporation assay and in the pre-incubation assay without metabolic activation revealed similar results. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the test substance is positive for mutagenicity to bacteria under the conditions of the test.
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